Obsessive Compulsive Disorder (OCD)NCT05160129
Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder
A study testing Selective focal stimulation of ALIC-pathways in people with Obsessive Compulsive Disorder (OCD), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Deep brain stimulation (DBS) is an effective treatment for people suffering from severe obsessive-compulsive disorder (OCD) whose symptoms have failed to improve after years and multiple methods of intervention. An effective DBS target for OCD is the anterior limb of the internal capsule (ALIC) brain region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- Selective focal stimulation of ALIC-pathways
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2021to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Primary psychiatric diagnosis of Obsessive-Compulsive Disorder (OCD, per DSM-5 criteria)
- Meets FDA Humanitarian Device Exemption (HDE) criteria for indication
- Has elected to receive clinically indicated DBS for OCD with a directional system outside of this research study, as determined by treating clinician(s) and per current clinical practice
- Minimum of a five-year history of treatment-refractory OCD with substantial functional impairment
- Failure of an adequate trial of at least three of the following SSRIs: Fluoxetine, Fluvoxamine, Citalopram, Escitalopram, Sertraline, Paroxetine
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- Failure of an adequate trial of clomipramine
- Failure of an adequate trial of one or more of the aforementioned antidepressants in combination with at least one of the following augmentation agents: Haloperidol, Risperidone, Olanzapine, Quetiapine, Ziprasidone, Aripiprazole
- Failure of an adequate trial of Cognitive Behavioral Therapy (CBT), defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist
- Minimum score of 25 on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at preoperative baseline
- Ability to undergo preoperative MRI
- English proficiency
- Capacity to provide written informed consent
- Willing and able to comply with all device operation and study-related procedures
Who cannot join
- Ineligible or unwilling to receive ALIC DBS for OCD
- Contraindications for general anesthesia, neurosurgery, or an MRI scan
- Neurological disorder or other significant brain pathology, such as moderate / marked cerebral atrophy, stroke, tumor, epilepsy, or previous neurosurgical procedures (excluding cingulotomy, which may be permitted if not contraindicated in the opinion of implanting neurosurgeon)
- Unstable medical illness, chronic immunosuppression, and/or considerably reduced life-expectancy
- Conditions requiring anticoagulant therapy which cannot be discontinued for the perioperative period, as required
- Conditions requiring certain regular MRI scans or diathermy
Show all 13Show fewer
- Currently implanted with a cardiac pacemaker / defibrillator or other implanted electrical device which may interfere with DBS stimulator or the function of which may be impacted by its implantation, in the opinion of evaluating neurosurgeon
- Other primary Axis I disorder or history of psychosis, such as schizophrenia, psychosis in the context of depressive or manic episode.
- Current or past history within the 6 months prior to DBS implantation of substance abuse or dependence (excluding nicotine and caffeine)
- Active suicidal ideation with intent, suicide attempt within the last six months, more than three suicide attempts within the last two years, or serious suicide risk as determined by the study psychiatrists
- Axis II disorders which, in the opinion of the study psychiatrist, may increases the risk of DBS to participants or cause study non-compliance
- Patients who lack the capacity to for proper device usage and maintenance, in the opinion of the research team
- Women who are pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martijn Figee contact
United States1 site, 1 recruiting
- Recruiting
Mount Sinai West
New York, New York, 10019
Martijn Figee, 212-523-8962, martijn.figee@mssm.edu
Martijn Figee
About this study
Deep brain stimulation (DBS) is an effective treatment for people suffering from severe obsessive-compulsive disorder (OCD) whose symptoms have failed to improve after years and multiple methods of intervention. An effective DBS target for OCD is the anterior limb of the internal capsule (ALIC) brain region. On average 60% of all OCD patients have a clinically significant response to ALIC DBS. However, ALIC DBS may become even more effective with the ability to predict which specific ALIC connections in the brain need to be stimulated for each individual OCD patient. This study therefore investigates personalized stimulation to the ALIC that allows for precise modulation of brain circuits associated with individual OCD symptoms. The study aims to specify the ideal anatomical target for ALIC DBS for maximum therapeutic benefit in each patient.
Read the detailed description
To improve DBS for severe OCD, the anatomical specificity with which stimulation is delivered must be enhanced. In this study, patients will receive personalized and circuit specific stimulation to five target ALIC pathways based on pre-surgery brain scan analysis where patient-specific blueprints are created and used to determine implant location. Stimulation to the ALIC is delivered by directional segmented electrodes which are designed to deliver precise activation of circuits of interest and minimize excess tissue activation that can cause side effects. In this study, ALIC DBS will target white matter pathways, each having different cortical projections that affect different behavioral outputs, instead of traditional targeting. Each of these chosen pathways have been shown to be involved in the effects of ALIC DBS for OCD, but the results vary between studies.
The current study involves routine implantation of bilateral DBS leads into the ALIC brain region, which are connected to an internal pulse generator (IPG) device that is implanted under the skin near the collar bone and controls stimulation delivery. Before surgery, patients will receive a high definition 7T MRI brain scan to carefully plan the personalized lead implantation. Following surgery, patients will receive routine clinical visits for optimizing the DBS parameters and monitoring of clinical effects. As part of this study, patients will participate in EEG recordings at stimulation initiation and after 6 and 12 months. In addition, patients will complete behavioral paradigm testing bimonthly during stimulation of circuit-specific DBS contacts.
The goal of this study is to create a blueprint map of the brain that characterizes pathways that are found in effective treatment of OCD. This will be done by determining which pathways are activated by stimulation in different locations in ALIC and linking these locations with changes in task performance. This will allow for specification of the ideal anatomical target for DBS for OCD for maximum therapeutic benefit.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- Selective focal stimulation of ALIC-pathways
- Keywords
- Deep Brain Stimulation (DBS), Obsessive Compulsive Disorder (OCD), Anterior Limb of Internal Capsule (ALIC), Circuit Modulation
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective focal stimulation of ALIC-pathwaysDevice
DBS will be applied selectively to different electrode contacts/ segments to evaluate clinical, behavioral, and electrocortical responses of specific pathways within the ALIC.
| Study group | Role | What they receive |
|---|---|---|
| Circuit-selective DBS | Experimental | People suffering from severe obsessive-compulsive disorder (OCD) Receives: Device: Selective focal stimulation of ALIC-pathways |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Yale Brown Obsessive Compulsive Scale (Y-BOCS)
This scale measures change in OCD symptom severity. Full scale from from 0 - 40 with higher score indicating more severe symptoms.
Measured: Pre-surgical baseline, monthly up to 12 months postoperative
Secondary outcomes (10)
Investment Task
This computational investment task provides a measure of reward valuation by measuring decision making related to different reward conditions.
Computational computer tasks: These behavioral tasks provide a measure of reward valuation, cognitive flexibility under conditions of uncertainty, and a measure of inhibitory control.
Measured: Pre-surgical baseline, bimonthly up to 12 months postoperative
Reversal Task
This computational reversal task provides a measure of cognitive flexibility under conditions of uncertainty.
Computational computer tasks: These behavioral tasks provide a measure of reward valuation, cognitive flexibility under conditions of uncertainty, and a measure of inhibitory control.
Measured: Pre-surgical baseline, bimonthly up to 12 months postoperative
Stop Signal Task
This computational stop signal task provides a measure of inhibitory control by assessing stop-signal reaction time.
Computational computer tasks: These behavioral tasks provide a measure of reward valuation, cognitive flexibility under conditions of uncertainty, and a measure of inhibitory control.
Measured: Pre-surgical baseline, bimonthly up to 12 months postoperative
Tractography pathway activation models (Diffusion-weighted-imaging)
Data collected from MRI scans will be used to measure structural connectivity in the brain (i.e., white matter pathways) that is used for surgical planning.
Measured: Baseline: Pre-surgery
Deep brain stimulation evoked potentials (EEG)
Evoked potentials provide a measure of electrophysiological, effective connectivity in the brain. Alpha, beta, theta, gamma and delta bandwidths will be assessed.
Measured: postoperative months 0, 6, 12
Change in Beck Depression Inventory (BDI)
This scale indicates the presence and severity of depressive symptoms. Full scale from 0 to 63 , with higher score indicating more severe depression.
Measured: Pre-surgical baseline, monthly up to 12 months postoperative
Change in Beck Anxiety Inventory (BAI)
This scale measures severity of anxiety symptoms. Full scale from 0 to 63, with higher score indicating more severe anxiety.
Measured: Pre-surgical baseline, monthly up to 12 months postoperative
Change in Barratt Impulsiveness Scale (BIS-11)
This is a clinical measure of impulsivity. Full scale from 30 -120, with a higher score indicating greater impulsivity.
Measured: Pre-surgical baseline, monthly up to 12 months postoperative
Change in Young Mania Rating Scale (YMRS)
This scale measures the presence and severity of mania. Full scale from 0 - 60, with higher scores indicating more severe mania.
Measured: Pre-surgical baseline, monthly up to 12 months postoperative
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
This scale measures risk of suicide on multiple dimensions, scored by answering "yes or no" questions where answers of "yes" may indicate risk. Full range from 0 to 9, with higher score indicating higher intensity suicidal ideation.
Measured: Pre-surgical baseline, monthly up to 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start13 Aug 2021
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Martijn Figee, Icahn School of Medicine at Mount Sinai
- Investigators
- Martijn Figee, Principal investigator, Icahn School of Medicine and Mount SinaiKi Sueng Choi, Principal investigator, Icahn School of Medicine and Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160129
- Sponsor's protocol ID
- STUDY-21-00125
- Other IDs
- 1R01MH123542-01
- Status last verified
- Jun 2026
- First submitted
- 17 Nov 2021
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT05160129
- Acronym / sponsor ID
- STUDY-21-00125
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- Deep Brain Stimulation (DBS), Obsessive Compulsive Disorder (OCD), Anterior Limb of Internal Capsule (ALIC), Circuit Modulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Deep brain stimulation (DBS) is an effective treatment for people suffering from severe obsessive-compulsive disorder (OCD) whose symptoms have failed to improve after years and multiple methods of intervention. An effective DBS target for OCD is the anterior limb of the internal capsule (ALIC) brain region. On average 60% of all OCD patients have a clinically significant response to ALIC DBS. However, ALIC DBS may become even more effective with the ability to predict which specific ALIC connections in the brain need to be stimulated for each individual OCD patient. This study therefore investigates personalized stimulation to the ALIC that allows for precise modulation of brain circuits associated with individual OCD symptoms. The study aims to specify the ideal anatomical target for ALIC DBS for maximum therapeutic benefit in each patient.
Detailed description
To improve DBS for severe OCD, the anatomical specificity with which stimulation is delivered must be enhanced. In this study, patients will receive personalized and circuit specific stimulation to five target ALIC pathways based on pre-surgery brain scan analysis where patient-specific blueprints are created and used to determine implant location. Stimulation to the ALIC is delivered by directional segmented electrodes which are designed to deliver precise activation of circuits of interest and minimize excess tissue activation that can cause side effects. In this study, ALIC DBS will target white matter pathways, each having different cortical projections that affect different behavioral outputs, instead of traditional targeting. Each of these chosen pathways have been shown to be involved in the effects of ALIC DBS for OCD, but the results vary between studies.
The current study involves routine implantation of bilateral DBS leads into the ALIC brain region, which are connected to an internal pulse generator (IPG) device that is implanted under the skin near the collar bone and controls stimulation delivery. Before surgery, patients will receive a high definition 7T MRI brain scan to carefully plan the personalized lead implantation. Following surgery, patients will receive routine clinical visits for optimizing the DBS parameters and monitoring of clinical effects. As part of this study, patients will participate in EEG recordings at stimulation initiation and after 6 and 12 months. In addition, patients will complete behavioral paradigm testing bimonthly during stimulation of circuit-specific DBS contacts.
The goal of this study is to create a blueprint map of the brain that characterizes pathways that are found in effective treatment of OCD. This will be done by determining which pathways are activated by stimulation in different locations in ALIC and linking these locations with changes in task performance. This will allow for specification of the ideal anatomical target for DBS for OCD for maximum therapeutic benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Circuit-selective DBS | Experimental | Device: Selective focal stimulation of ALIC-pathwaysPeople suffering from severe obsessive-compulsive disorder (OCD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 years of age or older
- Primary psychiatric diagnosis of Obsessive-Compulsive Disorder (OCD, per DSM-5 criteria)
- Meets FDA Humanitarian Device Exemption (HDE) criteria for indication
- Has elected to receive clinically indicated DBS for OCD with a directional system outside of this research study, as determined by treating clinician(s) and per current clinical practice
- Minimum of a five-year history of treatment-refractory OCD with substantial functional impairment
Key exclusion criteria (13 listed)
- Ineligible or unwilling to receive ALIC DBS for OCD
- Contraindications for general anesthesia, neurosurgery, or an MRI scan
- Neurological disorder or other significant brain pathology, such as moderate / marked cerebral atrophy, stroke, tumor, epilepsy, or previous neurosurgical procedures (excluding cingulotomy, which may be permitted if not contraindicated in the opinion of implanting neurosurgeon)
- Unstable medical illness, chronic immunosuppression, and/or considerably reduced life-expectancy
- Conditions requiring anticoagulant therapy which cannot be discontinued for the perioperative period, as required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective focal stimulation of ALIC-pathwaysDBS will be applied selectively to different electrode contacts/ segments to evaluate clinical, behavioral, and electrocortical responses of specific pathways within the ALIC. | Device | Circuit-selective DBS |
Primary outcome
Change in Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: Pre-surgical baseline, monthly up to 12 months postoperative
This scale measures change in OCD symptom severity. Full scale from from 0 - 40 with higher score indicating more severe symptoms.
10 secondary outcomes
Investment Task
Time frame: Pre-surgical baseline, bimonthly up to 12 months postoperative
Reversal Task
Time frame: Pre-surgical baseline, bimonthly up to 12 months postoperative
Stop Signal Task
Time frame: Pre-surgical baseline, bimonthly up to 12 months postoperative
Tractography pathway activation models (Diffusion-weighted-imaging)
Time frame: Baseline: Pre-surgery
Deep brain stimulation evoked potentials (EEG)
Time frame: postoperative months 0, 6, 12
Change in Beck Depression Inventory (BDI)
Time frame: Pre-surgical baseline, monthly up to 12 months postoperative
Change in Beck Anxiety Inventory (BAI)
Time frame: Pre-surgical baseline, monthly up to 12 months postoperative
Change in Barratt Impulsiveness Scale (BIS-11)
Time frame: Pre-surgical baseline, monthly up to 12 months postoperative
Change in Young Mania Rating Scale (YMRS)
Time frame: Pre-surgical baseline, monthly up to 12 months postoperative
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Pre-surgical baseline, monthly up to 12 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martijn Figee contact
Martijn Figee principal investigator
Icahn School of Medicine and Mount Sinai
Ki Sueng Choi principal investigator
Icahn School of Medicine and Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective focal stimulation of ALIC-pathways in people with Obsessive Compulsive Disorder (OCD), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abby Kiros (212-523-8279, abigeal.kiros@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Yale Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: Pre-surgical baseline, monthly up to 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.